A recognized pharmaceutical company has a great Remote opportunity awaiting a new Clinical Data Manager. In this role, the Clinical Data Manager will be responsible for contributing Data Management Support for assigned programs. The contractor is a self-motivated, collaborative clinical data management professional who is a self-starter and thrives in a fast-paced environment.
Responsibilities:
- Work with the Clinical Data Management (CDM) Lead to support operational activities for one or more programs
- Monitor data management vendor quality of work through key performance metrics
- Maintain program-level DM deliverable timelines in accordance with the program development strategy
- Support data management at cross-functional team meetings, providing accurate study status updates and proactive communication/escalation of data management issues and risks
- Draft eCRF design and edit check specifications; supports cross-functional review
- Perform cross-functional sponsor EDC user acceptance testing
- Interact with external data vendors and develop data transfer agreements
- Support the development and implementation of key data and metrics reports/listings
- Draft and review DM essential documents, including annotated CRFs, eCRF Completion Guidelines, Clinical Data Management Plans, and DB Go Live and Lock documentation
- 8+ years of Clinical Trial Data Management experience in the Pharma/Biotech industry
- Extensive technical experience using electronic data capture systems. Demonstrated experience with Medidata Rave.
- In-depth knowledge of DM industry standards, best practices, and CDISC/CDASH implementation
- Proficiency with the Microsoft Office Suite (Excel, Word, PowerPoint, Projec,t and Outlook)
- Effective in proactively identifying issues and supporting teams in the development of creative solutions and compliant decisions
- Demonstrate excellent verbal/written and interpersonal skills required to effectively communicate and collaborate in a cross-functional team environment
